BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1212101 · Received October 24, 2008

    Report

    Report Number
    1213643-2008-00466
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 1, 2003
    Report Date
    September 25, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE WAS IMPLANTED WITH COMPOSIX KUGEL MESH IN 2003 FOR REPAIR OF A VENTRAL HERNIA. SINCE THE MESH IMPLANT, PATIENT REPORTS HE HAS HAD CONSTANT ISSUES WITH HIS "UPPER GI SYSTEM, PAIN, BLOCKAGES, AN INFECTION IN THE POST-OP PERIOD (NOT CURRENT), FINDS IT HARD TO EAT, AND HAS HAD UNINTENDED WEIGHT LOSS". HE REPORTS THAT HIS STOMACH FEELS "DOUBLE JOINTED" AND KNOTTED UP". THE PATIENT REPORTED THAT WHEN HE RECEIVED THE RECALL NOTICE, HE WENT BACK TO SEE HIS IMPLANT SURGEON REGARDING THE MESH AND A POSSIBLE EXPLANT, AND, WAS TOLD BY THE SURGEON THAT HE "DIDN'T WANT TO TOUCH IT" HIS "LIVER IS NOT TOO GOOD". PATIENT REPORTED HE HAS "MILD CASE" OF HEPATITIS C. PATIENT WENT TO SEE ANOTHER SURGEON FOR A POSSIBLE EXPLANT, AND REPORTS THAT HE WAS TOLD THAT IF A MESH EXPLANT IS TO BE PERFORMED, A PLASTIC SURGEON WOULD ALSO NEED TO BE INVOLVED FOR "RECONSTRUCTION" OF HIS STOMACH AND INSIDES SINCE HIS HERNIAS ARE "SO MASSIVE". THE PROCEDURE WOULD ALSO NEED TO INCLUDE "DRAINAGE OF THE BILE BLOCKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43CND393

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention